Kornimate/medical-research-clean huggingface dataset:
clinical trial of transtek body fat analyzer (gbf-1251-b & other 3 models)

Conditions: Weight; Body Fat Disorder; Bone Mass

Summary: the clinical protocol of the clinical testing of this device: 1. objective of the test: to verify the functions and efficiency of devices. 2. test methods and procedures: comparison test. 3. device under test (dut): transtek body fat analyzer, model: gbf-1251-b, bf-1255-b, bf-1256-b, and gbf-1257-b. 4. comparison device: transtek, glass body fat analyzer, gbf-950-d. 5. study endpoints: dut and the comparison device are substantial equivalence. 6. statistical methodology used: description of statistical methods.

1. test purpose: the aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by dut and reference device. 2. target subject: the subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. 3. test procedures: 1. record the name, age, gender, and height of each subject. 2. let subject seated calmly for two minutes before test, dry the feet. 3. use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value. 4. for each subject, repeat 3) to get 3 pairs measurements. 5. repeat step 1) to 4) for every device (dut: gbf-1251-b, bf-1255-b, bf-1256-b, and gbf-1257-b; and reference device: gbf-950-d). 6. repeat step 1) to 5) for each subject. 4. note: 1. no motion and speaking are allowed during the measurement. 2. all dut use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency. 3. test environment: temperature: 22±1℃; relative humidity: 40\~70%.

Eligibility criteria:
inclusion criteria: * male,female exclusion criteria: * below 18 years old

Keywords: weight total body water body fat muscle mass bone mass
continuous glucose monitoring in pregnant women undergoing betamethasone therapy

Conditions: Pregnancy Complications

Summary: we hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. this understanding will hopefully allow us to better anticipate the risk of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal glucose to prevent maternal and neonatal complications of hyperglycemia.

pregnant patients who are undergoing inpatient betamethasone therapy as part of their clinical care will be eligible for the study. once the clinical team and patients have agreed to pursue betamethasone therapy, the patients' treating physician or nurse will inquire if the patient is interested in participating in our study protocol. those patients who are interested in participation will be consented by either a member of the treatment team or the study team. prior to receiving the first betamethasone dose, a soft sensor for continuous glucose monitoring system (cgms) will be inserted superficially under the skin. for those patients who will be receiving a scheduled course of betamethasone, the sensor may be inserted up to 24 hours prior to the betamethasone administration. the patient will be instructed on how to wear and care for the device. she will wear the cgms for the duration of her hospitalization or for up to 7 days total, whichever time period is shorter. for those patients who are diabetic, they will receive normal finger stick blood glucose (fsbg) monitoring and insulin therapy as determined by their treating physicians. those patients who are not diabetic will need to have 2 fsbg checks each day to correlate with the device. abnormal values will be reported to the patients' treating physician and addressed by the treating physician. prior to being discharged from the hospital, the patient will have the device removed. the patient will otherwise be treated routinely. we will record baseline demographic information and medical history from each of the women. we will also record information from the neonates' newborn medical records.

Eligibility criteria:
inclusion criteria:- 18 years of age or older * receiving betamethasone as part of routine clinical care. * pregnancy between 23+5 and 35+0 weeks exclusion criteria:- less than 18 years old. * major fetal anomalies * use of steroid medications in the past 2 weeks.
efficacy and safety of inclisiran as monotherapy in patients with primary hypercholesterolemia not receiving lipid-lowering therapy.

Conditions: Hypercholesterolemia

Summary: ckjx839d12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce ldl-c as measured by percentage change from baseline to day 150. this study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (llt), with a 10-year atherosclerotic cardiovascular disease (ascvd) risk of less than 7.5%.

this study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any llt with a 10-year ascvd risk score of less than 7.5%. this study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo. the study consists of: * a screening period of up to 14 days; * a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and * a safety follow-up / end of study visit conducted 30+5 days after the day 150 visit. the overall study duration is approximately 190 days.

Eligibility criteria:
inclusion criteria to be met at screening: * informed consent must be signed prior to participation in study * fasting ldl-c of \>= 100mg/dl but \< 190mg/dl * fasting triglycerides \<= 400 mg/dl * 10-year ascvd risk score \< 7.5% * not on any lipid-lowering therapy within 90 days key exclusion criteria: * history of ascvd * diabetes mellitus or fasting plasma glucose of \>= 7.0 mmol/l or hba1c \>= 6.5% * secondary hypercholesterolemia, e.g. hypothyroidism (tsh above upper limit of normal) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: inclisiran ezetimibe ldl-c monotherapy primary hypercholesterolemia
pet/ct imaging of upar-expression in patients with neuroendocrine tumors using 68ga-nota-ae105

Conditions: Neuroendocrine Tumors

Summary: the aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of upar pet/ct with the radioligand 68ga-nota-ae105 in patients with neuroendocrine tumors (nets).

68ga-nota-ae105 is a radioligand targeting urokinase plasminogen activator receptor (upar), which is a promising imaging biomarker of tumor aggressiveness. a total of 120 net patients will be subjected to a upar-pet/ct scan. follow-up will be performed (from the time of the angiogenesis pet/ ct) at 6 months for disease specific survival (dss) and a 1 year follow-up for pfs and os. the uptake of 68ga-nota-ae105 in tumor lesions will be quantified as standardized uptake values (suvmax/suvmean) and compared with pfs, dss and os (dichotomized above/below median suvmax and analyzed by kaplan-meier)

Eligibility criteria:
inclusion criteria: * diagnosed with gastro-entero-pancreatic neuroendocrine tumors (gep-net; grade: g1-g3) or broncho-pulmonary net. * who performance status 0-2 * must be able to read and understand the patient information in danish and to give informed consent exclusion criteria: * pregnancy * breast-feeding * weight more than the maximum weight limit for the pet/ct bed of the scanner (140 kg) * history of allergic reaction attributable to compounds of similar chemical or biologic composition to 68ga-nodaga-e\[c(rgdyk)\]2 * in case of broncho-pulmonary net, the subtype must not be small cell lung cancer (sclc)

Keywords: urokinase plasminogen activator receptor upar pet/ct positron emission tomography neuroendocrine tumors
mandibular advancement planning based on clinical overjet

Conditions: Overjet; Class II Division 1 Malocclusion

Summary: this prospective study aims to simulate the maximum mandibular advancement in class ii patients treated by herbst mth appliance on the base on clinical overjet. initial intraoral scans will be uploaded in suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an anterior occlusal contact will be reached. this virtual advancement will be compared to the real advancement obtained at the end of the herbst phase. this protocol will be applied to two groups: one with traditional dental occlusion, the second one with skeletal anchorage reinforcement and elastic chains


Eligibility criteria:
inclusion criteria: * anb\>=4° * overjet \>=4 mm * class ii malocclusion ( bilateral class ii molar relation, at least half a cusp) exclusion criteria: * tooth agenesis * poor oral hygiene * previous orthodontic treatments * systemic disease or bone pathology
short term results of tele-rehabilitation

Conditions: COVID-19; Dyspnea

Summary: most people who have coronavirus disease (covid-19) recover completely without any sequelae. however, some patients continue to experience symptoms of covid-19 even though their tests turn negative. this clinical spectrum that occurs after acute infection is called the post-covid syndrome (pcs). dyspnea, pain, decreased exercise capacity, limitations in activities of daily living, poor sleep quality, anxiety and depression are common symptoms in pcs. the aim of our study is to examine the effect of tele-rehabilitation-based exercise program on dyspnea, pain, functional capacity, sleep quality, anxiety and depression in individuals with pcs.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-75, * being in stable medical condition, conscious and cooperative, * having had covid and continuing symptoms * volunteering to participate in the study, * own a device that can be connected online independently or with support from family members. exclusion criteria: spo2 \< 92%, * hypotension (systolic blood pressure \< 90 mmhg or diastolic blood pressure \< 60mmhg) * having chronic respiratory disease (copd, asthma, etc.) * having a stroke or neurodegenerative disease. * not being willing to participate in the study

Keywords: tele-rehabilitation covid-19
micro-tech fnb needle to obtain tissue specimens of pancreas malignancy for personalized based chemotherapy

Conditions: Pancreatic Cancer

Summary: systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue samples, which are often obtained during endoscopic ultrasound (eus) by fine needle aspiration (fna) or fine needle biopsy (fnb). obtaining core biopsies by fnb has several potential benefits, such as making a more reliable diagnosis, performing immunohistochemistry for diagnostic reasons and in the future obtaining enough malignant cells to deliver personalized based chemotherapy regimen based on mutations detected by next generation sequencing. obtaining high quality and sufficient tumor material is essential for genomic profiling with a preference of fnb over fna. up to now, no specific fnb needle has been found to be superior in diagnostic accuracy and in obtaining tissue for genomic profiling. in this study, we aim to evaluate the diagnostic accuracy of a new fnb needle (micro-tech europe gmbh, düsseldorf, germany) and we study the adequacy of the obtained tissue samples for performing genetic sequencing.

this study is an international multicenter prospective cohort study. the study will be performed in collaboration with the disciplines of gastroenterology and pathology of the participating hospitals.

Eligibility criteria:
inclusion criteria: * 18 years and older * clinical suspicion of pancreatic adenocarcinoma * indication for obtaining eus-guided histology of a suspected pancreatic lesion * written informed consent exclusion criteria: * contra-indications to undergoing an eus (e.g., oropharyngeal abnormalities) * altered anatomy (e.g., after previous whipple-operation, roux-and-y gastrojejunostomy) * contra-indications to the administration of benzodiazepines, propophol or opioids * pregnancy * insufficient knowledge of the dutch language to be able to understand the patient information
haplo-identical/mismatched hematopoietic stem cell transplantation for myelodysplastic syndrome

Conditions: Advanced MDS Without Identical Sibling Donor

Summary: allogeneic hematopoietic stem cell transplantation (hsct) is currently the only curative treatment for myelodysplastic syndrome (mds), especially for advanced mds (blast \>5%). however, many patients cannot find an hla-matched donor. haploidentical donor is an alternative stem cell source. the study hypothesis: haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome


Eligibility criteria:
inclusion criteria: * patients with mds (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression * without identical sibling donor exclusion criteria: * contraindication to hsct * pregnancy * mental illness
a working memory training to decrease rumination in depressed and anxious individuals

Conditions: Major Depression; Anxiety Disorder

Summary: dysfunctioning executive functioning, including working memory (wm), is related to rumination. findings show that working memory capacity (wmc) can be increased by training. the current study explored by means of a double-blind randomized controlled trial whether an adaptive wm training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.


Eligibility criteria:
inclusion criteria: * major depression diagnosis * anxiety diagnosis exclusion criteria: * current psychosis * substance abuse

Keywords: rumination working memory depression anxiety working memory training overgeneral memories
the efficacy of pain management with self-reporting pain monitoring system in cancer patient

Conditions: Pain

Summary: to compare the pain scales between clinician evaluated and reported with wearable device by patients.

to compare the pain scales between clinician evaluated and reported with wearable device by patients with cancer of advanced stage.

Eligibility criteria:
inclusion criteria: * over 20 year old * cancer pain with visual analog scale or numeric rating scale score \>/- 4 * opioids candidates * with informed consent form exclusion criteria: * life expectancy within 3 months

Keywords: cancer pain, wearable device
the interaction between calcium and vitamin d intake

Conditions: Osteoporosis

Summary: we will study the relative importance of high calcium intake and vitamin d supplementation for calcium homeostasis, as determined by serum parathyroid hormone (pth) and biochemical bone markers. we also intend to examine the interaction of vitamin d and calcium intake on calcium homeostasis. we hypothesize that optimal calcium supplementation and optimal vitamin d supplementation will lead to lower serum levels of pth and markers of bone resorption compared with the placebo. we also theorize that when taken together, optimal calcium supplementation and optimal vitamin d intake will result in lower serum levels of pth and bone markers compared with calcium or vitamin d taken alone.


Eligibility criteria:
inclusion criteria: * healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more) exclusion criteria: * any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (bmi\>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination. * subjects with osteoporosis of the hip (total hip t-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded. * pregnancy. * use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics). * significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator. * patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded. * participation in another investigational trial in the past 30 days prior to the screening evaluation. * unexplained weight loss of \>15% during the previous year or history of anorexia nervosa. * medications that interfere with vitamin d metabolism. * patients with a habitual dietary calcium intake that exceeds 800 mg/day. * smokers greater than 1 pack per day will be excluded. * patients reporting alcohol intake greater than 2 drinks daily. * serum 25-hydroxyvitamin d level \> 75 nmol/l.

Keywords: bone resorption calcium homeostasis bone markers calcium and vitamin d supplementation parathyroid hormone levels interaction between calcium and vitamin d supplementation
photodynamic therapy in treating patients with skin cancer

Conditions: Non-melanomatous Skin Cancer; Precancerous Condition

Summary: rationale: photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. purpose: this randomized phase ii trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

objectives: * determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions. outline: this is a randomized study. patients are stratified according to lesion type (superficial basal cell carcinoma \[bcc\] vs nodular bcc vs superficial squamous cell carcinoma vs actinic keratoses). individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ala). ala is topically applied in a cream mixture and an occlusive dressing is placed over the lesion. after the randomized duration of ala application has expired, the dressing is removed and a dye laser is used to treat the lesion. patients are followed for 2-5 years after treatment. projected accrual: up to 200 patients could be accrued, assuming 1 lesion per patient. 50 lesions are required for each stratified group.

Eligibility criteria:
disease characteristics: * diagnosis of 1 of the following: * actinic keratoses * histologically proven superficial or nodular basal cell carcinoma (bcc), squamous cell carcinoma in situ (bowen's disease), or microinvasive squamous cell carcinoma * no nodular bcc greater than 4 mm thick that will not be surgically removed * no carcinoma with uncertain margins requiring moh's surgery patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no known photosensitivity disease * no porphyria or hypersensitivity to porphyrins prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation

Keywords: basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis
mechanical ventilation in interstitial lung disease

Conditions: Interstitial Lung Disease; Mechanical Ventilation; Risk Factors; Morality

Summary: to identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.


Eligibility criteria:
inclusion criteria: 1. they were clearly diagnosed as interstitial lung disease in hospital; 2. they had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in icu; 3. they received at least 48 hours of mechanical ventilation after being admitted into icu. exclusion criteria: * we excluded patients who were admitted into icu because of postoperative monitoring.
taste disorders and their relation to bmi, ffq, and eortc qlq-br23 in breast cancer patients during chemotherapy.

Conditions: Breast Cancer; Taste Disorders; Dysgeusia; Ageusia; Quality of Life

Summary: taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia a prospective case- only observational study was conducted in patients of the hospital general de méxico for two years. a self-reported taste survey was used, and patients scored their results in a likert scale.


Eligibility criteria:
inclusion criteria: - chemotherapy with doxorubicin + cyclophosphamide (dc) or paclitaxel + carboplatin (pc) or docetaxel. exclusión criteria: * no smokers infections in oral cavity acute respiratory diseases gastro- oesophageal reflux disease other types of cancer.
lamictal tm, haloperidol decanoate in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the effect of lamotrigine augmentation of haloperidol decanoate in the treatment of resistant schizophrenia predominantly by verbal resistant hallucinosis: a randomized, double-blind, placebo-controlled, study. nadir a.aliyev \& zafar n.aliyev central mental clinic for outpatients of baku city of azerbaijan republic abstract: objective: the current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.

method:a structured clinical interview, for dsm-iv axis i disorder, patient edition, was used to diagnose schizophrenia according to dsm-iv. three hundred fifty patients were studied. the patients were then randomly divided into two groups on 175 subjects in each group. first group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. data for clinical assessments were collected at weeks 0, 6 and 12 weeks. the expressiveness of psychopathology was estimated on panss. test response in both groups was defined as a reduction in the panss by using analysis of variance and chi-square tests.

Eligibility criteria:
exclusion criteria: * display an acute systemic medical disorder or a medical disorder requiring frequent changes in medication; * display a history of seizures, cerebrovascular disease, structural brain damage, from trauma, focal neurological sings on examination, or evidence of any progressive neurological disorder, substance dependence (except tobacco). inclusion criteria: * age from 18-60; * both gender; * resistant scizophrenia patients; * previous treatment history; * verbal resistant hallucinosis.

Keywords: schizophrenia lamictal tm haloperidol decanoate